Handheld ophthalmic laser system with replaceable contact tips and treatment guide

ABSTRACT

In some embodiments, an ophthalmic laser system may be provided that does not include a traditional laser console. Instead, the treatment device may be configured to house the treatment light source within the device handle. Additionally, in some embodiments, the handheld treatment device may include a user interface, such as dials and buttons, for adjusting various parameters of the therapeutic light. With certain embodiments, the self-contained handheld treatment device may be operated independent of an AC power source. For example, in some embodiments, the handheld treatment device may be battery powered. Additionally, the handheld treatment device may be disposable or may utilize replaceable distal tips in certain embodiments. Certain embodiments may be particularly designed for transscleral cyclophotocoagulation. Also, treatment guides are provided that may be configured to couple with a treatment device to align the device with a target tissue of the eye.

CROSS REFERENCE TO RELATED APPLICATION DATA

This application claims priority to and the benefit of U.S. ProvisionalPatent Application No. 62/357,012 filed on Jun. 30, 2016, the fulldisclosure of which is incorporated herein by reference in its entiretyfor all purposes.

BACKGROUND OF THE DISCLOSURE

The present disclosure is generally related to medical systems, devices,and methods for treating a glaucomatous eye. In some embodiments, ahandheld treatment device is configured for delivering therapeutic lighttoward a target tissue. The handheld treatment device may be providedwith a replaceable distal contact tip. In further embodiments,ophthalmic treatment systems may be provided that include a treatmentdevice for delivering therapeutic light toward a target tissue and atreatment guide for placement against an eye of a patient that mayinterface with the distal end of the treatment device to align thedevice with one or more treatment locations about the eye of thepatient.

Glaucoma is a leading cause of blindness. Glaucoma involves the loss ofretinal ganglion cells in a characteristic pattern of optic neuropathy.Untreated glaucoma can lead to permanent damage of the optic nerve andresultant visual field loss, which can progress to blindness. The lossof visual field due to glaucoma often occurs gradually over a long timeand may only be recognized when the loss is already quite advanced. Oncelost, this damaged visual field can never be recovered.

Elevated intraocular pressure (IOP) is a significant risk factor fordeveloping glaucoma. IOP is a function of production of aqueous humor bythe ciliary body of the eye and its drainage through the trabecularmeshwork and all other outflow pathways including the uveoscleralpathway. Aqueous humor is a complex mixture of electrolytes, organicssolutes, and other proteins that supply nutrients to thenon-vascularized tissues of the anterior chamber of the eye. It flowsfrom the ciliary bodies into the posterior chamber, bounded posteriorlyby the lens and the ciliary zonule and bounded anteriorly by the iris.Aqueous humor then flows through the pupil of the iris into the anteriorchamber, bounded posteriorly by the iris and anteriorly by the cornea.In the conventional aqueous humor outflow path, the trabecular meshworkdrains aqueous humor from the anterior chamber via Schlemm's canal intoscleral plexuses and the general blood circulation. In open angleglaucoma there is reduced flow through the trabecular meshwork. In angleclosure glaucoma, the iris is pushed forward against the trabecularmeshwork, preventing the egress of fluid.

Uveoscleral outflow is a non-conventional pathway that is gainingimportance in the management of glaucoma. In uveoscleral outflow,aqueous humor enters the ciliary muscles from the anterior chamber andexits through the supraciliary space and across the anterior orposterior sclera. Uveoscleral outflow may contribute significantly tototal aqueous humor outflow.

Currently, glaucoma therapies aim to reduce IOP by either limiting theproduction of aqueous humor or by increasing the outflow of aqueoushumor. Medications such as beta-blockers, carbonic anhydrase inhibitors,etc., are used as the primary treatment to reduce the production ofaqueous humor. Medications may also be used as the primary therapy toincrease the outflow of the aqueous humor. Miotic and cholinergic drugsincrease the trabecular outflow, while prostaglandin drugs, for example,Latanoprost and Bimatoprost, increase the uveoscleral outflow. Thesedrugs, however, are expensive and have undesirable side effects, whichcan cause compliance-dependent problems over time.

Surgery may also be used to increase the outflow or to lower theproduction of aqueous humor. Laser trabeculoplasty is the application ofa laser beam over areas of the trabecular meshwork to increase theoutflow. Cyclocryotherapy and laser cyclophotocoagulation are surgicalattempts to lower the production of aqueous humor by the ciliaryprocesses. Although they may be effective, these destructive surgicalinterventions are normally used as a last resource in the management ofglaucoma due to the risk of the severe complication of phthisis bulbi.Other adverse side effects of cyclodestructive surgical procedures mayinclude ocular hypotony and inflammation of the anterior eye segment,which may be associated with an increased incidence of maculacomplications. Still other adverse side effects include transienthyphaema and exudates in the anterior chamber, uveitis, visual loss, andnecrotizing scleritis.

In laser transscleral cyclophotocoagulation, high intensity continuouswave (CW) infrared laser energy is directed through selected portions ofthe pars plicata region to the ciliary body, structures under thescleral layers and the overlying conjunctiva. Selected portions of theciliary body and related processes are permanently destroyed, therebydecreasing the overall production of aqueous humor. Laser energy may bedirected through air to a patient seated at a special slit lamp.Alternatively, laser energy may be delivered through the use of fiberoptic handpieces placed in contact with the patient's eyeball. In bothlaser energy delivery methods, however, accurately and repeatedlydirecting a laser beam to a subsurface non-visible target such as theciliary body can be challenging for a surgeon.

While the prior systems, methods, and devices have provided advancementsin the art, further improvements are desired.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure generally relate to ophthalmiclaser treatment systems. In some embodiments, the ophthalmic lasertreatment systems may include a handheld treatment device having areplaceable distal tip. In further embodiments, the ophthalmic lasertreatment system may include a treatment guide configured to cooperatewith a handheld treatment device to preferentially align the treatmentdevice with a target tissue of the eye of a patient. In some aspects,the treatment device may be provided to direct therapeutic light towardthe ciliary process. For example, in certain embodiments, the treatmentdevice and/or guide may be provided for cyclophotocoagulation of the eyeof a patient.

In an embodiment of the disclosure, a handheld glaucoma treatment devicefor delivering therapeutic light toward a ciliary process of an eye of apatient may be provided. The handheld glaucoma treatment device mayinclude a treatment device housing defining a treatment device handlefor grasping by a hand of a user. The housing may have a proximal endand a distal end opposite the proximal end. A therapeutic light sourcemay be housed within the treatment device housing. Optics may also behoused within the treatment device housing and may be configured todirect therapeutic light generated by the therapeutic light sourcetoward the distal end of the treatment device housing. A replaceablecontact tip having a proximal end and a distal end may be provided. Theproximal end of the replaceable contact tip may be configured to bereleaseably coupled with the distal end of the treatment device housing.A contact surface of the distal end of the replaceable contact tip maybe configured to couple, contact, and/or engage with a surface of theeye. The replaceable contact tip may be configured to receivetherapeutic light generated by the therapeutic light source via theoptics housed within the treatment device housing and may be configuredto direct the received therapeutic light toward the eye.

Optionally, the treatment device housing may house a power supplyconfigured to power the therapeutic light source. The power supply maybe a battery (e.g., single use or rechargeable).

The treatment device housing may define an elongate axis from theproximal end to the distal end of the treatment device housing. Thetherapeutic light may be projected distally along the elongate axis. Thecontact surface of the replaceable contact tip may be at a non-ninetydegree angle with respect to the elongate axis defined by the treatmentdevice housing (e.g., such that the therapeutic light is directed at anon-normal angle relative to the contact surface of the replaceablecontact tip). For example, the contact surface of the replaceablecontact tip may be at a 30-60 degree angle with respect to the elongateaxis defined by the treatment device housing.

In some embodiments, the contact surface of the replaceable contact tipmay be concave to match a curvature of a portion of the eye. Forexample, in some embodiments, the contact surface may be configured tomatch a curvature of the sclera of the eye.

In some embodiments, the distal end of the replaceable contact tip mayhave an alignment edge or feature configured to be aligned with a limbusof the eye.

Optionally, the contact surface of the distal end of the replaceablecontact tip may be convex. The replaceable contact tip may includerounded edges so that the distal end of the replaceable contact tip maybe swept across the surface of the eye. In certain embodiments, therounded edges reduce the likelihood that the distal end of thereplaceable contact tip catches on the tissue surface of the eye whenthe treatment device is swept across the surface of the eye.

The replaceable contact tip may include internal optics configured tooptically couple with the optics housed within the treatment devicehousing. For example, the optics of the replaceable contact tip may bean optical fiber having a proximal end and a distal end. The proximalend may optically couple with the optics housed within the treatmentdevice housing when the replaceable contact tip is engaged with thedistal end of the treatment device housing. The distal end of theinternal optics of the replaceable contact tip may protrude from thecontact surface of the replaceable contact tip. For example, the distalend of the optical fiber may protrude from the contact surface of thereplaceable contact tip by 1 mm or less (e.g., 0.5 mm as is the case forIRIDEX G-probe).

In other embodiments, the distal end of the optical fiber may protrudefrom the contact surface of the replaceable contact tip by 2-10 mm ormore (e.g., 5 mm).

In some embodiments, the proximal end of the replaceable contact tipcouples with the distal end of the treatment device housing through athreaded engagement. Optionally, the proximal end of the replaceablecontact tip couples with the distal end of the treatment device housingthrough a snap-fit engagement.

In still further embodiments, the replaceable contact tip may beconfigured to map the received therapeutic light generated by thetherapeutic light source into a plurality of separate smaller spots sothat a plurality of treatment locations may be treated simultaneously.

For example, in certain embodiments, the replaceable contact tip mayreceive a 1 mm input light and may map the input light with a spot sizeof 1 mm into a plurality of 10 μm spots or smaller.

Optionally, the replaceable contact tip may be configured to map thereceived therapeutic light into 2 to 100 spots (e.g., 49 spots in someembodiments).

In some embodiments of the present disclosure, the replaceable contacttip may be one of a plurality of replaceable contact tips. Each of theplurality of replaceable contact tips may be provided for differenttreatments (e.g., using different therapeutic light parameters) or mayhave different distal end configurations (e.g., for coupling withdifferent target areas of the eye, for cooperating with a treatmentguide, for different methods of therapeutic light delivery, or thelike).

For example, the plurality of replaceable contact tips may include afirst replaceable contact tip and a second replaceable contact tip. Thesecond replaceable tip may have a proximal end and a distal end. Theproximal end of the second replaceable contact tip may be configured tobe coupled with the distal end of the treatment device housing. Acontact surface of the distal end of the second replaceable contact tipmay be configured to engage with the surface of the eye. The distal endof the second replaceable contact tip may have a different configurationthan the distal end of the other replaceable contact tip (firstreplaceable contact tip) and may engage with the eye in a differentmanner.

In some embodiments, the first replaceable contact tip may have a firstcomputer readable code and the second replaceable contact tip may have asecond computer readable code. The treatment device housing may includea device (e.g., scanner) for detecting the first and second computerreadable code to determine which of the first and second replaceablecontact tips is coupled with the distal end of the treatment devicehousing. Parameters of the therapeutic light source may be adjustedbased on which of the first and second computer readable codes isdetected by the scanner.

In further aspects of the present invention, an ophthalmic treatmentsystem may be provided that includes a handheld glaucoma treatmentdevice for delivering therapeutic light toward a ciliary process of aneye of a patient. The handheld glaucoma treatment device may include atreatment device housing defining a treatment device handle for graspingby a hand of a user. The treatment device housing may have a proximalend and a distal end opposite the proximal end. A therapeutic lightsource may be housed within the treatment device housing. Optics may behoused within the treatment device housing configured to directtherapeutic light generated by the therapeutic light source toward thedistal end of the treatment device housing. A replaceable contact tipmay be provided, having a proximal end and a distal end. The proximalend of the replaceable contact tip may be configured to be detachablycoupled with the distal end of the treatment device housing. Thereplaceable contact tip may be configured to receive therapeutic lightgenerated by the therapeutic light source via the optics housed withinthe treatment device housing and may be configured to direct thereceived therapeutic light toward the eye. The ophthalmic treatmentsystem may further include a treatment guide having a distal surfaceconfigured to be placed against a surface of the eye and a proximalsurface of the treatment guide being configured to interface with thedistal end of the replaceable contact tip to align the replaceablecontact tip with one or more treatment locations around the eye.

The replaceable contact tip may include internal optics configured tooptically couple with the optics housed within the treatment devicehousing. The optics of the replaceable contact tip may be an opticalfiber having a proximal end optically coupled with the optics housedwithin the treatment device housing when the replaceable contact tip iscoupled with the distal end of the treatment device housing. The opticalfiber may have a distal end that protrudes from a contact surface of thedistal end of the replaceable contact tip.

The treatment guide may include an aperture extending from the proximalsurface to the distal surface. The aperture may be configured to receivethe distal end of the optical fiber that protrudes distally from thedistal end of the replaceable contact tip and may be configured to alignthe optical fiber with a target tissue. In some embodiments, theaperture may restrict movement of the optical fiber when the distal endof the optical fiber is received into the aperture.

A thickness of the treatment guide from the distal surface to theproximal surface and a length of the optical fiber that protrudesdistally from the distal end of the replaceable contact tip may bedimensioned so that the distal end of the optical fiber protrudesdistally from the distal surface of the treatment guide when the opticalfiber is received through the aperture of the treatment guide. Thethickness of the treatment guide and the length of the optical fiber maybe dimensioned so that the distal end of the optical fiber protrudesdistally by at least 1 mm from the distal surface of the treatment guidewhen the optical fiber is received thought the aperture of the treatmentguide.

The treatment guide may be a contact ring with a plurality of aperturesextending from the proximal surface to the distal surface. The aperturesmay be radially spaced about the contact ring. In some embodiments, thedistal surface of the treatment guide may be curved to conform with theedge contour of the eye (e.g., sclera).

In some embodiments, the replaceable contact tip cooperates with theapertures of the treatment guide to deliver therapeutic light toward atarget tissue at an angle not parallel to an optical axis of the eye.

Optionally, the aperture may be a track and the replaceable contact tipmay be configured to slidably engage with the track such that thereplaceable contact tip can translate along the track while deliveringtherapeutic light to the target tissue.

The treatment guide may include a perimeter wall configured to engagewith an eyelid of the patient and may be configured to maintain theeyelid open during application of the treatment guide against thesurface of the eye.

In some embodiments, the treatment guide, the treatment device, or both,may incorporate an illumination light source for transillumination ofthe eye for the purpose of confirming the location of ciliary bodies orother subsurface ocular structures. In some embodiments, theillumination light source may be coupled with one or more light pipes tofacilitate transillumination.

In some aspects, a treatment guide may be provided according to someembodiments of the disclosure. The treatment guide may have an inneredge configured to be aligned with a limbus of the eye. A distal surfaceof the treatment guide may be configured to be placed against a surfaceof the eye and a proximal surface being configured to interface with adistal end of a treatment device contact tip to guide the contact tip toone or more treatment locations around the eye.

The treatment guide may include an aperture extending from the proximalsurface to the distal surface. The aperture may be configured to receivethe distal end of an optical fiber that protrudes distally from thedistal end of the contact tip and may be configured to align the opticalfiber with a target tissue.

The treatment guide may be a contact ring with a plurality of aperturesextending from the proximal surface to the distal surface. The aperturesmay be radially spaced about the contact ring.

In some embodiments, the contact tip may cooperate with the apertures ofthe treatment guide to deliver therapeutic light toward a target tissueat an angle not parallel to an optical axis of the eye.

The aperture may be a track and the contact tip may be configured toslidably engage with the track such that the contact tip can translatealong the track while delivering therapeutic light to the target tissue.

The track may extend at least 30 degrees about the optical axis of theeye. For example, the track may extend 180 degrees about the opticalaxis of the eye and in some embodiments, the track may extend at least270 degrees about the optical axis of the eye.

Optionally, the treatment guide may include a perimeter wall configuredto engage with an eyelid of the patient and may be configured tomaintain the eyelid open during application of the treatment guideagainst the surface of the eye.

In still further embodiments, a method for treating an eye of a patientmay be provided. The method may include engaging a proximal end of areplaceable contact tip with a distal end of a treatment device housingto optically couple the replaceable contact tip with a therapeutic lightsource housed within the treatment device housing. A distal end of thereplaceable contact tip may be aligned with the ciliary process of theeye. Thereafter the therapeutic light source may be activated togenerate therapeutic light and the therapeutic light may be deliveredtoward the ciliary process of the eye.

In some embodiments, the method may further include applying a treatmentguide to the eye. Aligning the distal end of the replaceable contact tipwith the ciliary process of the eye may include engaging the distal endof the replaceable contact tip with the treatment guide after thetreatment guide is applied to the eye.

In some embodiments, the treatment guide may be a ring and may bepositioned over the sclera of the eye of the patient.

In some embodiments, the treatment guide may include a plurality ofseparate apertures configured to receive a distal end of an opticalfiber of the replaceable contact tip therethrough.

Optionally, the replaceable contact tip engages with the apertures ofthe treatment guide to deliver therapeutic light toward the ciliaryprocess at an angle not parallel to an optical axis of the eye incertain embodiments.

The distal end of the optical fiber of the replaceable contact tip maybe configured to protrude from a distal surface of the treatment guideand may indent the surface of the eye.

The treatment guide may include a track in some embodiments. Thereplaceable contact tip may slidably engage with the track and thereplaceable contact tip may be translated along the track duringdelivery of the therapeutic light to the ciliary process.

In some embodiments, the treatment guide may include a perimeter wallconfigured to engage with an eyelid of the patient. The perimeter wallof the treatment guide may maintain the eyelid open during applicationof the treatment guide to the eye.

In some embodiments, the method may include removing a prior contact tipfrom the treatment device housing prior to engaging the proximal end ofthe replaceable contact tip with the distal end of the treatment devicehousing. In some embodiments, the replaceable contact tip may include acomputer readable code. The treatment device housing may include ascanner for detecting the first computer readable code. Parameters ofthe therapeutic light source may be adjusted after detection of thefirst computer readable code by the scanner.

Embodiments of the disclosure covered by this patent are defined by theclaims below, not this summary. This summary is a high-level overview ofvarious aspects of the disclosure and introduces some of the conceptsthat are further described in the Detailed Description section below.This summary is not intended to identify key or essential features ofthe claimed subject matter, nor is it intended to be used in isolationto determine the scope of the claimed subject matter. The subject mattershould be understood by reference to appropriate portions of the entirespecification of this patent, any or all drawings and each claim.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details, aspects, and embodiments of the disclosure will bedescribed by way of example only and with reference to the drawings. Inthe drawings, like reference numbers are used to identify like orfunctionally similar elements. Elements in the figures are illustratedfor simplicity and clarity and have not necessarily been drawn to scale.

FIG. 1A shows the anatomy of an eye with relevant parts labeled toprovide anatomical references;

FIG. 1B shows further details of the eye anatomy;

FIG. 2 illustrates an exemplary ophthalmic treatment device according tosome embodiments of the disclosure;

FIG. 3 illustrates an exemplary ophthalmic treatment device aligned witha target tissue according to some embodiments of the disclosure;

FIG. 4 illustrates exemplary treatment spots about the sclera accordingto some embodiments;

FIG. 5 illustrates another exemplary ophthalmic treatment device alignedwith a target tissue according to some embodiments of the disclosure;

FIG. 6 illustrates exemplary treatment sweeps about the sclera accordingto some embodiments;

FIG. 7 illustrates exemplary laser parameters for treating an eyeaccording to some embodiments;

FIG. 8 illustrates an exemplary replaceable contact tip that may be usedwith ophthalmic treatment devices and systems of the present disclosureaccording to some embodiments;

FIG. 9A illustrates another exemplary replaceable contact tip that maybe used with ophthalmic treatment devices and systems of the presentdisclosure according to some embodiments;

FIG. 9B illustrates another exemplary replaceable contact tip that maybe used with ophthalmic treatment devices and systems of the presentdisclosure according to some embodiments;

FIG. 10 illustrates the ophthalmic treatment device of FIG. 2 placedagainst the eye of a patient according to some embodiments;

FIG. 11 illustrates an exemplary demultiplexer that may be used withcertain embodiments of the present disclosure;

FIG. 12 illustrates another exemplary replaceable contact tip that maybe used with ophthalmic treatment devices and systems of the presentdisclosure according to some embodiments;

FIG. 13 illustrates another exemplary replaceable contact tip that maybe used with ophthalmic treatment devices and systems of the presentdisclosure according to some embodiments;

FIG. 14 illustrates top view of an exemplary treatment guide accordingto some embodiments of the disclosure;

FIG. 15 illustrates a side cross-sectional view of the treatment guideof FIG. 14 according to some embodiments of the disclosure;

FIG. 16 illustrates an exemplary engagement between a replaceablecontact tip and a treatment guide according to some embodiments of thedisclosure;

FIG. 17 illustrates another exemplary treatment guide according to someembodiments of the disclosure; and

FIG. 18 illustrates an exemplary method of treating an eye according tosome embodiments of the disclosure.

FIG. 19 illustrates an exemplary treatment device with a flexibleoptical cable coupling a contact tip with a device body, according tosome embodiments of the disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Ophthalmic laser systems generally require a laser console and a laserprobe where the laser console contains the laser source, power supplyand controller. The laser probe generally contains an optical fiber andconnector for attachment to the laser console. The laser console istypically an AC powered system, placed on a surface that is at leastseveral feet away from a patient's eye, and the laser output light fromthe console is typically carried by an optical fiber (i.e., waveguide)to the patient's eye where photocoagulation based treatment may takeplace. Such a system typically requires external AC power, a longmultimode fiber to bring light to the end applicator that could beimplemented with a slit lamp adapter, a scanner, or a handheld contactprobe.

Embodiments of the present invention may provide certain advantages andimprovements over standard ophthalmic laser systems. For example, insome embodiments, an ophthalmic laser system may be provided that doesnot include a traditional laser console. Instead, the treatment devicemay be configured to house the treatment light source within the devicehandle. Additionally, in some embodiments, the handheld treatment devicemay include a user interface, such as dials and buttons, for adjustingvarious parameters of the therapeutic light. With certain embodiments,the self-contained handheld treatment device may be operated independentof an AC power source. For example, in some embodiments, the handheldtreatment device may be battery powered. Additionally, the handheldtreatment device may be disposable or may utilize replaceable distaltips in certain embodiments. Many embodiments may be particularlydesigned for transscleral cyclophotocoagulation where energy is directedthrough selected portions of the pars plicata region to the ciliarybody, structures under the scleral layers, and the overlying conjunctivato treat a glaucomatous eye.

FIGS. 1A-1B illustrate details of the anatomy of an eye. For example,FIG. 1A shows the anatomy of an eye 1 with relevant parts labeled toprovide anatomical references. The sclera 2 is a tough sheath around theeye which meets the cornea 3 at a circular junction called the limbus 4.Behind the cornea 3 lies the iris 5, the lens 6 and the ciliary body andrelated processes 7. The anterior chamber is the fluid-filledcompartment within the eye 1 just in front of the pupil 8. Viewed inprofile, the anterior chamber is bounded by the domed cornea 3 in frontand by the colored iris 5 behind. Where the cornea 3 and the iris 5converge they form an angle 9 referred to herein as the angle of theanterior chamber. Further eye 1 may have a visual/optical axis 10. FIG.1B shows further details of the surgical eye anatomy.

Embodiments of treatment devices described herein may target intraocularstructures that span from the posterior pars plicata to the pars plana.For example, in some embodiments, the treatment devices may be used totarget the ciliary body and/or pars plana. Alternatively, the pars planamay be targeted and the pars plicata, ciliary body, and/or other ciliaryprocesses avoided and vice versa. FIG. 2 illustrates an exemplaryophthalmic treatment device 100 (e.g., probe) according to someembodiments of the disclosure that may be used to target intraocularstructures as described above. The ophthalmic treatment device 100 maycomprise a treatment device body 102 and a replaceable or single-use tip104 that is detachably coupled with the treatment device body 102. Thetreatment device body 102, may include a housing 106 with an exteriorsurface that defines a handle for grasping by a user. The treatmentdevice body 102 may further include the therapeutic light source 108,associated electronics 110, one or more batteries 112, a user interface114, and/or internal optics 116.

The ophthalmic treatment device 100 may be used to deliver therapeuticlight to a target tissue of the eye in a variety of different methods.For example, U.S. Patent Publication 2010/0076419, incorporated hereinby reference in its entirety, describes a method of delivering energytoward target tissues at a plurality of spaced apart fixed locations.FIG. 3 illustrates an exemplary placement of an exemplary treatmentdevice 100 a with the eye 1 according to some embodiments of thedisclosure. The device 100 a may be positioned against the sclera 2 andaligned with the limbus 4 of the eye 1. For example, the inner edge ofthe distal contact end may be aligned with the limbus 4. In someembodiments, the device 100 a may be held parallel to the visual axis 10of the eye 1. The device 100 a may then apply energy to a plurality ofspaced apart fixed locations 117 about the limbus 4, as illustrated inFIG. 4.

Additionally, U.S. Patent Publication 2015/0374539, incorporated hereinby reference in its entirety, describes another treatment method where atreatment device may be slid or swept across the target tissueconcurrently with the light delivery. For example, FIG. 5 illustrates anexemplary placement of another exemplary treatment device 100 b with theeye 1, according to some embodiments of the disclosure. The device 100 bmay be positioned against the sclera 2 and aligned with the limbus 4 ofthe eye 1. In some embodiments, the device 100 b may be held at an anglethat is not parallel to the visual axis of the eye 1. For example, insome embodiments, the device 100 b may be held about perpendicular tothe sclera 2. The device 100 b may then be slid or swept across thesclera 2 about the limbus 4 during application of the light energy. Forexample, FIG. 6 illustrates a first sweeping motion 118 from about a9:30-2:30 clock position, and a separate sweeping motion 119 from abouta 3:30-8:30 clock position. While these treatment methods are describedin detail, it should be understood they are exemplary and non-limiting.Device placement against and alignment with the eye may be variable andlight delivery may vary in other embodiments of the present disclosure.

In some embodiments, the therapeutic light source 108 may be asemi-conductor laser diode or an LED, or the like. In some embodiments,the therapeutic light source 108 may deliver infrared laser energy froma pulsed 810 nm diode laser. In certain embodiments, the therapeuticlight source 108 and associated electronics 110 may be configured todeliver light energy in a pulsed or continuous wave emission mode.

For example, in some embodiments, the light source 108 and associatedelectronics 110 may be configured to operate with a 30% duty cycle, withan “on” time of about 500 μs and an “off” time of about 1100 μs, about a15% duty cycle, with an “on” time of about 300 μs and an “off” time ofabout 1700 μs, or about a 10% duty cycle, with an “on” time of about 200μs and an “off” time of about 1800 μs. Careful selection of the laserenergy pulse “on” and “off” times can avoid undesired thermal damage toa target by allowing the target to cool during the “off” time of thelaser before the next pulse of energy is delivered during the “on” time.The duty cycle may be selected so that cumulative thermal buildup,caused by insufficient cooling during the “off” time may be avoided.Thus, damage may be reduced to a minimum level sufficient to trigger abiological response needed for lowering of intraocular pressure (TOP).FIG. 7 illustrates an exemplary pulsed mode that may be used in someembodiments of the present invention. The illustrated mode may have an“on” time of 100 μs and an “off” time of 1900 μs with a period of 2000μs.

In some embodiments where the device is slid across the treatment regionof the eye, the treatment laser delivered may comprise pulsed laserenergy (e.g., pulsed infrared laser energy). The pulsed laser energy mayhave a duty cycle between 0.1%-99% and a period of 1 to 5 ms whendelivering the laser treatment in a sliding manner. Preferably, the dutycycle may be between 1-5% when delivering the laser treatment in asliding manner. These ranges may also be advantageous for transscleraltreatment delivery.

In some embodiments, the device may incorporate a laser, LED or otheroptical source capable of directly stimulating a therapeutic response byimproving cellular functionality, for example upregulating thebiochemical pathways responsible for energy production by mitochondria.A device may incorporate one or more such therapeutic optical sources.

In typical embodiments, a semiconductor laser diode or a semiconductorlaser diode pumped laser (e.g., DPSS green/yellow laser) is used as thelight source for ophthalmic therapy. Such lasers have defined lasingwavelengths such as 532 nm, 577 nm or 810 nm, and have defined spectralline width such as +/−3 nm, and have defined threshold current such as700 mA for an 810 nm laser diode, and have defined electrical impedancesthat allow the lasers to be electrically or optically modulated at anyrepetition rate (such as 1 kHz or higher), with pulse width at any value(such as 1 ns or higher), for an extended period of time (such as 1 msor longer).

The light source in the embodiments could be a single mode laser such asa DFB laser, a multimode laser such as an 808 nm broad area laser, or abroad spectrum LED such as a visible spectrum LED for different colors(e.g., green, yellow, or red). The pulse energy, pulse width and pulserepetition rate (aka duty cycle) can be adjusted to provide optimumtreatment effect such as demonstrated by the MicroPulse parameters.

Electronics 110 may further include a feedback control implemented inhardware to control the light source 108 power that is faster than theresponse of a software control loop. The hardware optical power feedbackcontrol is preferably implemented with a commercially available laserdriver chip that has built-in automatic power control feature that usesphotodetector input that correlates with laser output to directlycontrol the bias current of the laser diode to achieve constant powerlevel. This typically results in fast real time power control whencompared with a software feedback loop.

In some embodiments, batteries 112 can be an alkaline battery, lead-acidbattery, lithium-ion battery, or any other rechargeable or disposablebattery. The device body 102 may include a battery receptacle forreceiving battery 112 and the housing 106 may include a removable coverfor battery 112 replacement when needed, in certain embodiments. The useof a battery 112 to power a therapeutic light source 108 housed in thesame housing 16 may allow for more convenient treatments as the device100 may not need to be tethered to a separate laser console. The lack oftethering to a laser console may also allow for a greater freedom ofmotion with the device 100 and better targeting of tissues.Additionally, in some embodiments, the battery powered device 100 mayallow for the use of the device 100 in rural or secluded areas whereelectricity is not available. Additionally, embodiments of device 100housing the light source 108 and the power source 112 may potentiallyreduce manufacturing costs which may allow for greater availability ofdevice 100 in emerging markets. The batteries could be of rechargeabletype and the charging could be done wirelessly.

User interface 114 may comprise one or more mechanical dials, buttons,or switches that may be used to adjust parameters of the therapeuticlight source with or without a touchscreen or a dedicated electronicdisplay. The user interface may or may not employ a touch screendisplay. When a non-touch-screen user interface is employed, simplemechanical display using digits to indicate laser settings could beused. Additionally or alternatively, treatment parameters may becommunicated to the device via radio frequency, e.g., Bluetooth.

The housing 106 may further house internal optics 116 that guide thelight generated from the light source 108 toward the distal end 120 ofhousing 106. The terms “proximal” and “distal” are to be taken asrelative to the handheld device 100. “Proximal” is to be understood asrelatively close to the practitioner holding the device and “distal” isto be understood as relatively farther away from the practitionerholding the device. In some embodiments, the internal optics 116 mayinclude beam shaping optical components such as a collimating lensmechanically and optically coupled with the light source 108. Theinternal optics may also include any necessary beam shaping elements.Focus and other beam conditioning optics may be separable or integratedwith other elements of the light source within the device.

In some embodiments, the housing 106 may optionally include anillumination light source. The illumination light source may beconfigured to direct light into the eye to illuminate the ciliaryprocess, as described in U.S. Patent Publication 2015/0305938,incorporated by reference herein in its entirety. The illuminated tissuemay help a clinician or other practitioner align the device 100 with thetissue during therapeutic light delivery.

The replaceable tip 104 may comprise a proximal end 122 and a distalapplicator end 124 opposite the proximal end 122. The replaceable tip104 may further include optics 126 and, in some embodiments, thereplaceable tip 104 may include an optical sensor 144, reflector 146,and/or computer readable media 150 as described in more detail below.

The proximal end 122 of the replaceable tip 104 may be configured tomechanically couple with the distal end 120 of the housing 106 of body102 using one or more engagement features. For example, FIG. 8illustrates an exemplary replaceable tip 104 a, where the proximal end122 of the replaceable tip 104 a has a threaded engagement feature.Accordingly tip 104 a may be rotatably engaged and disengaged with thehousing 106 of device body 102 having the corresponding threadedengagement feature.

FIG. 9A illustrates another exemplary replaceable tip 104 b. Theexemplary replaceable tip 104 b includes a proximal end 122 includingone or more protrusions 123 that may snap fit within one or morecorresponding engagement features of the device body 102. It should beunderstood that these illustrated embodiments are exemplary andnon-limiting—other variations are possible. For example, in someembodiments, the device body 102 may have a male connector and thereplaceable tips 104 may have a female connector or vice-versa. In otherembodiments, there may be a length of fiber between the male and femaleconnectors to allow a flexible optical cable between the replaceable tipand the handheld light source. The use of a short optical cable is for,but not limited to, sterilization or other clinical needs. FIG. 9Billustrates yet another exemplary replaceable tip 104 f. The exemplaryreplaceable tip 104 f may be magnetically attached to the device body102 using magnets 142 (e.g., permanent magnets). For example, the tips104 and the device body 102 can include magnets or be made of or includemagnetic material.

In some embodiments, a contact surface of the distal end 124 of thereplaceable tip 104 may be angled relative to the direction in whichtherapeutic light is delivered. For example, FIG. 10 illustrates thedevice 100 of FIG. 2 placed against the eye of a patient. The angledcontact surface of distal end 124 may guide the therapeutic light beaminto the eye 1 at any preferred angle when the distal end 124 is placedagainst and aligned with the eye 1. In some embodiments, the distal end124 may be concave with a curvature configured to match the curvature ofthe sclera.

The replaceable tip 104 may include optics 126. The optics 126 ofreplaceable tip 104 may be passive. In some embodiments, the optics 126may be provided to focus the light into an area under the surface of theeye. Optionally, the optics 126 may diffuse the light into the areaunder the surface of the eye. In some embodiments, the optics 126 maycomprise a multimode fiber having a proximal end 128 and a distal end130. The proximal end 128 of optics 126 may be configured to opticallycouple with the optics 116 of device body 102. Additional couplingoptics may include any known in the prior art such as any waveguide thatconnect the ingress and egress ports, and any free-space opticalelements that map ingress to the egress port. The refractive index ofthe material at the distal end 130 of the tip is chosen to matchapproximately the refractive index of the human tear in the eye to allowhigh percentage transfer of optical power to target tissue. The distalend 130 of optics 126 may form a blunt tip. In some embodiments, thedistal end 130 of optics 126 may be formed by melting back the terminalend of the multimode fiber. As such, in some embodiments, the distal end130 may be hemispherical in configuration. While optics 126 areillustrated as a multimode fiber, it should be understood that otherpassive optics may be utilized in other embodiments. For example, thepassive optics may comprises any number of lenses, reflectors,refractors, non-imaging optics, and/or imaging optics.

In some embodiments, the tip of distal end 130 may protrude from 0.15 mmto 1.0 mm (e.g., 0.25 mm-4 mm) beyond the contact surface of distal end124. The protrusion of the tip 130 may increase the transmission ofinfrared laser energy through the conjunctiva and sclera and may providebeam divergence to irradiate the ciliary body structures from theanterior (pars plicata) through the posterior (pars plana) portions ofthe ciliary body.

In some embodiments, the optics 126 of tip 104 may include ademultiplexer. For example, FIG. 11 illustrates an exemplarydemultiplexer 134 that may be used with certain embodiments of thepresent disclosure. The demultiplexer 134 may have a proximal end 136and a distal end 138. The demultiplexer 134 may be configured to maptherapeutic light inputted from the proximal end 136 into a plurality ofsmaller spots 140 at the distal end 138. In some embodiments, thedemultiplexer 134 may be a fused glass piece. In certain embodiments,the demultiplexer 134 map a 1000 μm input spot into multiple smallerspots (e.g., 10 μm or the like) spread over a larger area than the 1000μm input spot. While illustrated as mapping the input light into threesmaller spots 140, it should be understood that this is exemplary andnon-limiting. Optionally, a demultiplexer 134 may map the inputtherapeutic light into two or more smaller spots. For example, in someembodiments, it may be beneficial to map an input therapeutic light to64 or more spots. This may allow multiple locations to be treated with asingle input light.

In some embodiments of the disclosure, the replaceable tip 104 mayinclude at least one optical sensor 144 (e.g., a photodiode) thatdetects reflected or scattered light by eye tissue from therapeuticlight directed at the eye tissue during treatment. The reflected orscattered light may be converted into an output signal (e.g., anelectrical signal) by the optical sensor 144 and used to assess orcalculate incident laser power. The output signal of the optical sensor144 may be carried across an interface 152 between the tip 104 anddevice housing 106 by, for example, electrical contacts as described inmore detail below. In some embodiments, the output signal or calculatedincident laser power can be displayed on the user interface 114. Inother embodiments, the replaceable tip 104 can include other types ofsensors (e.g., power or pressure).

In certain embodiments of the disclosure, the replaceable tip 104 mayinclude computer readable media 150. The computer readable media 150 maybe an optical barcode (e.g., 2D barcode), embedded chip (e.g.,encryption, RFID, NFC, direct read memory chip) or the like. Thecomputer readable media 150 may be read by a corresponding sensor orscanner associated with the device body 150. In some embodiments, thecomputer readable media 150 may be a security feature that protects thedevice body 102 from being used with unauthorized (e.g., used orcounterfeit) replacement tips 104. For example, an encryption or RFIDchip may enforce single use of the replaceable tips 104 for eachtreatment. Optionally, the computer readable media 150 may carrytreatment parameter information associated with the replaceable tip 104.For example, a replaceable tip 104 may be coupled with the device body102. A sensor of the device body or separate sensor (e.g., on anexternal scanner) may read the computer readable media 150 to determinewhich treatment parameters are associated with the type of tip 104 thatis attached and/or whether the replaceable tip is unauthorized.Thereafter, the electronics 110 of the device body 102 may be configuredto automatically adjust parameters of the therapeutic light source 108for the particular treatment.

In some embodiments, the interface 152 may be a compositeoptical-electrical interface defined between the tip 104 and devicehousing 106. The interface can allow optical power and/or electricalsignals or circuits (e.g., encryption or RFID chips, antenna matchingcircuit) to cross between components (e.g., sensors) of the tip 104 andcomponents (e.g., electronics) positioned inside the housing 106. Insome embodiments, an optical fiber (e.g., with both optical fibers andelectrical wires) may be provided between the tip 104 and housing 106 toallow optical power and/or electrical signals or circuits to cross viathe interface. In other embodiments, the optical power and/or electricalsignals or circuits can cross the interface 152 via free-space.

In some embodiments of the disclosure, the replaceable tip 104 mayinclude at least one reflector 146. The reflector 146 can direct thelaser beam or therapeutic light to a second treatment site at an angle(e.g., perpendicular) relative to light being directed to a firsttreatment site. For example, in some embodiments, the reflector 146 candirect therapeutic light sideways relative to a longitudinal axis of thetip 104 in a manner known as “side-fire”. In this manner, therapeuticlight can be directed to treat tumors on an ocular surface of apatient's eye and/or to treat a second site different from the firstsite. For example, if the first site is the ciliary body in the eye, thesecond site may be a different intraocular or ocular surface structure.In some embodiments, the optics 126 can include side-fire opticalfibers.

While the illustrated distal end 124 of the replaceable tip 104 ofdevice 100 is angled, other configurations may be used in otherembodiments of the disclosure. For example, FIG. 12 illustrates anexemplary replaceable tip 104 c. Replaceable tip 104 c includes aproximal end 122 c and a distal end 124 c. The proximal end 122 c isconfigured to detachably couple with an associated device body 102. Thedistal end 124 c may be a rounded convex surface that does not match thecurvature of the sclera. The rounded convex surface may facilitatesweeping of the device over the sclera during ophthalmic treatment, asdescribed above with reference to FIG. 5 and FIG. 6.

FIG. 13 illustrates another exemplary replaceable contact tip 104 d thatmay be used with ophthalmic treatment devices and systems of the presentdisclosure according to some embodiments. Replaceable contact tip 104 dincludes an angled and concave distal end 124 d that is configured tomatch the curvature of the sclera. Tip 104 d may include an illuminationlight conduit 132. The illumination light conduit may couple with anillumination light source housed within the housing 106 of device body102. The conduit 132 may direct the illumination light distally towardthe eye to illuminate the ciliary process as described in U.S. PatentPublication 2015/0305938, previously incorporated by reference.

Optionally, to further facilitate alignment of a treatment device (e.g.,treatment device 100) with the target tissue, a treatment guide may beprovided. FIG. 14 illustrates a top view of an exemplary treatment guide200 according to some embodiments of the disclosure. FIG. 15 illustratesan exemplary side cross-sectional view of the treatment guide 200. Theguide may facilitate accurate targeting of a therapeutic light to thevarious target regions of the eye. Such a guide may help improveconsistency and accuracy in various glaucoma treatments since thedevices are typically handheld. The guide may comprise an annular guidewhich engages the eye tissue and guides manual movement of the device tothe multiple target regions. Such guides may be registered to and/ormounted on the patient and can provide tactile feedback, and safetyelements which inhibit device movement beyond a target tissue.Additionally, the guide may be adjustable so as to be reconfigurable tovarious eye sizes or to various treatments. In the alternative, theguide may attach to the device and move the device along the guiderelative to the tissue.

A treatment guide may include apertures of different sizes in certainembodiments, where each aperture is used for a specifically sizeddisposable tip. The shape of the contact tip may be a flat surface thatis the result of cleaving or polishing, or it may be a round surfacethat is the result of etching or burning process.

The treatment guide 200 may be a ring 202 in some embodiments. The ring202 may have a proximal surface 204 and a distal surface 206. The distalsurface 206 may be placed against the surface of the eye. For example,in some embodiments, the distal surface 206 may be placed against thesclera and about the cornea of the eye. In some embodiments, an inneredge of the ring 202 may be configured to be aligned with the limbus ofthe eye. The guide 200 may further include one or more apertures 208extending from the proximal surface 204 to the distal surface 206. Whileillustrated as planar, in some embodiments, the distal surface 206 ofguide 200 may be concave and configured to match the curvature of thesclera.

Optionally, the treatment guide 200 may include a perimeter wall 201that extends proximally from the distal surface 206 of the ring 202. Theperimeter wall may be configured to keep the eyelids of the patient openduring treatment.

The apertures 208 may be positioned about the ring 202 at locations toprovide a desired treatment. For example, in some embodiments, theapertures 208 may be between 2.5 mm-3.5 mm from the inner edge of thering 202 (or a distance optimized for a particular treatment). Asillustrated in FIG. 15, the apertures 208 may be at any angle relativeto the optical axis of the eye when the guide 200 is aligned andpositioned against the eye (for different eyes differently angleddesigns could be used). The angled apertures 208 may allow thetherapeutic light to enter the eye at the desired angle toward thetarget tissue.

In some embodiments, the apertures may be dimensioned to receive analignment feature of a corresponding treatment device to preferentiallyalign the treatment device at a desired angle relative to the eye. Forinstance, in some embodiments, the apertures 208 may be configured toreceive the distal end of the multimode fiber of the replaceable tip andto align the multimode fiber at the preferred angle with respect to thesurface of the eye. In some embodiments, the apertures 208 may bedimensioned to fit the multimode fiber of the replaceable tip so thatthe device is limited in translational movement relative to the guide.

FIG. 16 illustrates an exemplary engagement between a replaceablecontact tip 104 of a treatment device and a treatment guide 200according to some embodiments of the disclosure. As illustrated, in someembodiments, the distal end 130 of the multimode fiber of the contacttip 104 may extend into the aperture 208. In some embodiments, thedistal end 130 may extend distally from the distal surface 206 of thetreatment guide 200. In some embodiments, the length of the distal end130 and the thickness d of the treatment guide 200 from the proximalsurface 204 to the distal surface 206 may be dimensioned such that thefiber tip 130 extends 0.05 mm-1 mm distally from the distal surface 206of the treatment guide. For example, if the treatment guide 200 had athickness d of 2 mm, the fiber tip 130 may extend 2.05 mm-3 mm from thedistal surface 124 of the replaceable tip 104. Accordingly, thethickness d of the guide 200 may control a contact pressure of the fibertip 130 against the surface of the eye. Optionally, in some embodiments,a plurality of treatment guides 200 may be provided that have varyingthicknesses such that a clinician can select one that allows thepreferred amount of pressure in combination with a replaceable tip 104for the particular patient.

FIG. 17 illustrates a top view of another exemplary treatment guide 300according to some embodiments of the disclosure. The treatment guide 300may facilitate device alignment and tissue targeting for a treatmentwhere the treatment device is swept across the eye during therapeuticlight delivery.

The treatment guide 300 may be a ring 302 in some embodiments. Incertain implementations, an inner edge of ring 302 may be configured tobe aligned with a limbus of the eye. Optionally, a perimeter wall 301may be provided for engaging with the eyelids of a patient to maintainthe eyelids open during treatment. The ring 302 may have a proximalsurface 304 and a distal surface for engaging a surface of the eye. Forexample, in some embodiments, the distal surface may be placed againstthe sclera and about the cornea of the eye and the guide is positionedand fixed at the front of the eye by the force from the eyelids oroptionally by the force of the hand with the ring dimensionedappropriately to remain stationery during a treatment session.Optionally, the distal surface of guide 300 may be concave andconfigured to match the curvature of the sclera. The guide 300 mayfurther include one or more arcuate tracks 308 extending from theproximal surface 304 to the distal surface that is configured to engagewith a tip of a laser treatment device and to guide the tip of the lasertreatment device along the track 308 during therapeutic light delivery.In some embodiments, the track 308 may be dimensioned to receive thedistal end 130 of a replaceable tip 104 into the track 308. Optionally,the distal end 130 of the replaceable tip 104 may protrude distallythrough the thickness of the guide 308 such that the distal end 130 ofthe replaceable tip 104 may apply contact pressure against a surface ofthe eye.

In some embodiments, the track 308 may be spaced about 2.5 mm-3.5 mmfrom the inner edge of the ring 302. In some embodiments, the track 308may span 30 degrees-270 degrees of ring 302. Optionally, the track 308,similar to the apertures 208 described above, may be configured to allowtherapeutic light to enter at a desired angle into the eye.

In some embodiments, the need for eye stabilization will be eliminatedby a handheld laser and its tip-guide since the guide may be lodgedinside the eye and may move with the eye. Additionally, the free handmay hold the laser device to stay with the tip/guide so that alignmentis always maintained. While guide 200 was described above withsingle-use replaceable tips 104, it should be understood that thetreatment guides described herein may be used with laser devices havingreplaceable distal tips or may be used with other laser devices such asthose described in the references incorporated herein.

In certain embodiments, the treatment guides (e.g., guide 200, guide300) described herein may be constructed or manufactured by modifying astandard scleral lens. For example, the apertures, tracks, holes orslots of the guides can be formed or made in the scleral lens materialto provide a guide with certain features as described herein.

In still further embodiments, a method of a treatment of an eye may beprovided. FIG. 18 illustrates an exemplary method 400 according to someembodiments of the disclosure. The method 400 may include attaching areplaceable contact tip to the treatment device housing 402. A computerreadable code (e.g., code 150) associated with the replaceable contacttip may be detected 404. Therapeutic light parameters may be adjustedbased on the detected computer readable code 406. A treatment guide maybe placed on the eye 408. Thereafter, the replaceable contact tip may becoupled with the treatment guide to align the therapeutic light with thetarget tissue 410. After device alignment with the target tissue, thetherapeutic light may be delivered toward the target tissue 312.

A replaceable contact tip (e.g., tip 104) may be attached to thetreatment device housing (e.g., housing 106 of body 102) in any of themanners described above. For example, the tip may be threadably engaged,snap-fit, or magnetically engaged with a corresponding device body,and/or it is connected to the device housing with a flexible opticalfiber (e.g., pigtail optical fiber) that allows flexibility between thedevice housing and the replaceable tip.

FIG. 19 illustrates an exemplary treatment device 100 e having aflexible optical coupler 160 that couples a treatment device body 102with a replaceable contact tip 104 e, according to some embodiments ofthe disclosure. The treatment device body 102 may be similar to thatbody illustrated in FIG. 2. The device body 102 may house a therapeuticlight source, associated electronics, and a portable power source.Additionally device body 102 may incorporate the user interface 114. Theuser interface is illustrated as a simple switch or button that may bedepressed to activate the therapeutic light source housed therein todeliver therapeutic light toward the distal end 120 of the body 102.While illustrated as a simple button, the user interface 114 may furtherinclude other switches and/or dials for adjusting parameters of thetherapeutic light source as described above.

The flexible optical coupler 160 may comprise a flexible optical fiber161 (e.g., pigtail optical fiber). A proximal end of the flexibleoptical fiber 161 may be coupled with a proximal connector 162. A distalend of the flexible optical fiber 161 may be coupled with a distalconnector 164. The proximal connector 162 may be configured tomechanically couple with the distal end 120 of the device body 102,(threadably, snap-fit, magnetically, or the like). Once the proximalconnector 162 is coupled with the distal end 120 of the device body 102,the flexible optical fiber 161 may be optically coupled with thetherapeutic light source housed within the device body 102. The distalconnector 164 of the flexible optical coupler 160 may be configured tomechanically couple with the proximal end 122 e of the replaceable tip104 e (threadably, snap-fit, magnetically or the like). Once the distalconnector 164 is coupled with the proximal end 122 e of the replaceabletip 104 e, the internal optics of the replaceable tip 104 e may beoptically coupled with the flexible optical fiber 161. With the assemblyof the device body 102, the flexible optical coupler 160, and thereplaceable tip 104 e, activation of the therapeutic light source housedwithin the device body 102 will be directed from the distal end 124 e ofthe replaceable contact tip 104 e.

In some embodiments, the proximal end 122 e of replaceable contact tip104 e may have a similar engagement configuration as the proximalconnector 162 of flexible optical coupler 160. Similarly, in someembodiments, the distal end 120 of device body 102 may have a similarengagement configuration as the distal connector 164 of flexible opticalcoupler 160. This may allow the system 100 e to be used with or withoutthe flexible optical coupler 160. For example, in certain treatmentswhere the flexible optical coupler 160 is unnecessary, a clinician maydirectly couple the replaceable tip 104 e with the device body 102 giventhat the proximal end 122 e of replaceable tip 104 e has a similarengagement configuration as the proximal connector 162 of flexibleoptical coupler 160, thereby allowing the proximal end 122 e of thereplaceable tip 104 e to couple with the distal end 120 of the devicebody 102.

In certain embodiments, when electronics are included or embedded in thetip 104 e, the optical fiber 161 can act as a compositeoptical-electrical cable with both an optical fiber and electrical wiresto provide an interface between the tip 104 e and body 102 for theelectrical and optical signals as described above. In suchconfigurations, the connectors 162 and 164 may also support both theoptical fiber and electrical wires.

While the replaceable contact tip 104 e is illustrated as having a flatdistal contact end 124 e (perpendicular to the direction of lightdelivery), it should be understood that replaceable contact tip 104 emay have any configuration described above. For example, the replaceablecontact tip 104 e may be convex (e.g., for sliding treatments), concave(e.g., for mating with the surface of the eye), or angled (e.g., fordelivering therapeutic light at a preferred angle relative to thesurface of the eye). As set forth above many different replacement tipconfigurations may be provided for different treatments. Additionally,it should be understood that treatment device 104 e may be used with orwithout a treatment guide (e.g., guide 200, 300 or the like).

The computer readable code may be a barcode, RFID, or other electronicchip or the like, described above. The computer readable code may alsoact as a security feature that ensures that improper third partytreatment tips are not used with the device body 102. Accordingly, insome embodiments, the method may include verifying an authenticity ofthe replaceable tip coupled with the device body. Optionally,therapeutic light parameters may be adjusted based on the detectedcomputer readable code 406.

The treatment guide may be placed on the eye 408 for the appropriatetreatment. For example, if the treatment calls for a plurality ofindividual treatment spots, a treatment guide like guide 200 may beapplied to the eye. On the other hand, if the treatment calls fortherapeutic light delivery while the device is swept across a portion ofthe eye, a treatment guide like guide 300 may be applied to the eye.After placement of the guide on the eye, the replaceable contact tip maybe coupled with the treatment guide to align the therapeutic light withthe target tissue 410. As set forth above, in some embodiments, a distalend of a multimode fiber of the device tip may be inserted through anaperture or track of the guide to position and align the device tip withthe target tissue. Optionally, the distal end of the multimode fiber mayprotrude distally from the distal surface of the guide to apply pressureto the surface of the eye. After device alignment with the targettissue, the therapeutic light may be delivered toward the target tissue312.

One or more computing devices may be adapted to provide desiredfunctionality by accessing software instructions rendered in acomputer-readable form. When software is used, any suitable programming,scripting, or other type of language or combinations of languages may beused to implement the teachings contained herein. However, software neednot be used exclusively, or at all. For example, some embodiments of themethods and systems set forth herein may also be implemented byhard-wired logic or other circuitry, including but not limited toapplication-specific circuits. Combinations of computer-executedsoftware and hard-wired logic or other circuitry may be suitable aswell.

Embodiments of the methods disclosed herein may be executed by one ormore suitable computing devices. Such system(s) may comprise one or morecomputing devices adapted to perform one or more embodiments of themethods disclosed herein. As noted above, such devices may access one ormore computer-readable media that embody computer-readable instructionswhich, when executed by at least one computer, cause the at least onecomputer to implement one or more embodiments of the methods of thepresent subject matter. Additionally or alternatively, the computingdevice(s) may comprise circuitry that renders the device(s) operative toimplement one or more of the methods of the present subject matter.

Any suitable computer-readable medium or media may be used to implementor practice the presently-disclosed subject matter, including but notlimited to, diskettes, drives, and other magnetic-based storage media,optical storage media, including disks (e.g., CD-ROMS, DVD-ROMS,variants thereof, etc.), flash, RAM, ROM, and other memory devices, andthe like.

The subject matter of the present invention is described here withspecificity, but the claimed subject matter may be embodied in otherways, may include different elements or steps, and may be used inconjunction with other existing or future technologies.

This description should not be interpreted as implying any particularorder or arrangement among or between various steps or elements exceptwhen the order of individual steps or arrangement of elements isexplicitly described. Different arrangements of the components depictedin the drawings or described above, as well as components and steps notshown or described are possible. Similarly, some features andsub-combinations are useful and may be employed without reference toother features and sub-combinations. Embodiments of the invention havebeen described for illustrative and not restrictive purposes, andalternative embodiments will become apparent to readers of this patent.Accordingly, the present invention is not limited to the embodimentsdescribed above or depicted in the drawings, and various embodiments andmodifications may be made without departing from the scope of the claimsbelow.

What is claimed is:
 1. A handheld glaucoma treatment device fordelivering therapeutic light toward an eye of a patient, the handheldglaucoma treatment device comprising: a treatment device housingdefining a handle for grasping by a hand of a user having a proximal endand a distal end opposite the proximal end; a therapeutic light sourcedisposed within the treatment device housing; optics disposed within thetreatment device housing configured to direct therapeutic lightgenerated by the therapeutic light source toward the distal end of thetreatment device housing; a replaceable contact tip having a proximalend and a distal end, the proximal end of the replaceable contact tipconfigured to be detachably coupled with the distal end of the treatmentdevice housing and the distal end of the replaceable contact tipcomprising a contact surface configured to couple with a surface of theeye, the replaceable contact tip configured to receive therapeutic lightgenerated by the therapeutic light source via the optics housed withinthe treatment device housing and configured to direct the receivedtherapeutic light toward the eye.
 2. The handheld glaucoma treatmentdevice of claim 1, further comprising a power supply disposed within thetreatment device housing and configured to power the therapeutic lightsource, wherein the power supply comprises a battery.
 3. The handheldglaucoma treatment device of claim 1, wherein a shape of the replaceablecontact tip is a flat surface made from cleaving or polishing, or acurved surface made by an etching or burning process.
 4. The handheldglaucoma treatment device of claim 1, further comprising a flexibleoptical coupler for coupling the proximal end of the replaceable contacttip with the distal end of the treatment device housing, wherein theflexible optical coupler comprises a flexible optical fiber having aproximal end and a distal end, the proximal end of the flexible opticalfiber coupled with a proximal connector and the distal end of theflexible optical fiber coupled with a distal connector, and wherein theproximal connector comprises an engagement feature having the sameconfiguration as an engagement feature on a proximal end of thereplaceable contact tip, and wherein the distal connector comprises anengagement feature having the same configuration as an engagementfeature on a distal end of the treatment device housing.
 5. The handheldglaucoma treatment device of claim 1, wherein the contact surface of thedistal end of the replaceable contact tip is slanted so as to control anincidence angle of the light beam on the eye of the patient.
 6. Thehandheld glaucoma treatment device of claim 1, wherein the replaceablecontact tip defines an elongate axis from the proximal end to the distalend of the replaceable contact tip, wherein the therapeutic light isprojected distally along the elongate axis, and wherein the contactsurface of the distal end of the replaceable contact tip is at anon-perpendicular angle with respect to the elongate axis defined by thereplaceable contact tip, wherein the contact surface of the distal endof the replaceable contact tip is at a 30-60 degree angle with respectto the elongate axis defined by the replaceable contact tip.
 7. Thehandheld glaucoma treatment device of claim 1, wherein the distal end ofthe replaceable contact tip is concave to match a curvature of a portionof the eye.
 8. The handheld glaucoma treatment device of claim 1,wherein the distal end of the replaceable contact tip is convex andincludes rounded edges so that the contact surface of the replaceablecontact tip may be swept across the surface of the eye.
 9. The handheldglaucoma treatment device of claim 1, wherein the replaceable contacttip comprises internal beam forming optics configured to opticallycouple with the optics housed within the treatment device housing,wherein the optics of the replaceable contact tip comprises an opticalfiber having a proximal end optically coupled with the optics housedwithin the treatment device housing when the replaceable contact tip iscoupled with the treatment device housing and a distal end thatprotrudes from the contact surface of the replaceable contact tip. 10.The handheld glaucoma treatment device of claim 9, wherein the distalend of the optical fiber protrudes from the contact surface of thereplaceable contact tip by 1 mm or less.
 11. The handheld glaucomatreatment device of claim 9, wherein the distal end of the optical fiberprotrudes from the contact surface of the replaceable contact tip by 6mm or more.
 12. The handheld glaucoma treatment device of claim 1,wherein the proximal end of the replaceable contact tip couples with thedistal end of the treatment device housing through a threadedengagement, a snap-fit engagement, or a magnetic coupling.
 13. Thehandheld glaucoma treatment device of claim 1, wherein the replaceablecontact tip is configured to map the received therapeutic lightgenerated by the therapeutic light source into a plurality of separatesmaller spots.
 14. The handheld glaucoma treatment device of claim 13,wherein the replaceable contact tip receives an input light with a 1 mmspot size and maps the input light with the 1 mm spot size into aplurality of 10 μm spots or smaller.
 15. The handheld glaucoma treatmentdevice of claim 13, wherein the replaceable contact tip is configured tomap the received therapeutic light into 49 smaller spots.
 16. Thehandheld glaucoma treatment device of claim 1, wherein the replaceablecontact tip is a first replaceable contact tip and wherein the handheldglaucoma treatment device further comprises a second replaceable contacttip having a proximal end and a distal end, the proximal end of thesecond replaceable contact tip configured to be coupled with the distalend of the treatment device housing and the distal end of the secondreplaceable contact tip comprising a contact surface configured tocontact the surface of the eye, and wherein the distal end of the secondreplaceable contact tip has a different configuration than the distalend of the first replaceable contact tip.
 17. The handheld glaucomatreatment device of claim 16, wherein the first replaceable contact tipcomprises a first computer readable code, wherein the second replaceablecontact tip comprises a second computer readable code, and wherein thetreatment device housing includes a scanner for detecting the first andsecond computer readable code to determine which of the first and secondreplaceable contact tips is coupled with the distal end of the treatmentdevice housing, wherein parameters of the therapeutic light source areadjusted based on which of the first and second computer readable codesis detected by the scanner.
 18. The handheld glaucoma treatment deviceof claim 1, further comprising an interface configured to allow opticaland electrical signals to pass between the replaceable tip and thedevice housing, wherein the replaceable contact tip comprises an opticalsensor or an encryption chip.
 19. An ophthalmic laser treatment systemcomprising: a handheld treatment device for delivering therapeutic lighttoward an eye of a patient, the handheld treatment device comprising: atreatment device housing defining a handle for grasping by a hand of auser having a proximal end and a distal end opposite the proximal end; atherapeutic light source disposed within the treatment device housing;optics disposed within the treatment device housing configured to directtherapeutic light generated by the therapeutic light source toward thedistal end of the treatment device housing; a replaceable contact tiphaving a proximal end and a distal end, the proximal end of thereplaceable contact tip configured to be detachably coupled with thedistal end of the treatment device housing, the replaceable contact tipconfigured to receive therapeutic light generated by the therapeuticlight source via the optics housed within the treatment device housingand configured to direct the received therapeutic light toward the eye;and a treatment guide having a distal surface configured to be placedagainst a surface of the eye and a proximal surface of the treatmentguide being configured to interface with the distal end of thereplaceable contact tip to align the replaceable contact tip with one ormore treatment locations around the eye.
 20. The ophthalmic treatmentsystem of claim 19, wherein the replaceable contact tip comprisesinternal optics configured to optically couple with the optics housedwithin the treatment device housing.
 21. The ophthalmic treatment systemof claim 20, wherein the optics of the replaceable contact tip comprisesan optical fiber having a proximal end optically coupled with the opticshoused within the treatment device housing and a distal end thatprotrudes distally from a contact surface of the distal end of thereplaceable contact tip.
 22. The ophthalmic treatment system of claim21, wherein the treatment guide comprises at least one apertureextending from the proximal surface to the distal surface, the at leastone aperture configured to receive the distal end of the optical fiberthat protrudes distally from the contact surface of the replaceablecontact tip and to align the optical fiber with a target tissue.
 23. Theophthalmic treatment system of claim 22, wherein a thickness of thetreatment guide from the distal surface to the proximal surface and alength of the optical fiber that protrudes distally from the contactsurface of the replaceable contact tip are dimensioned so that thedistal end of the optical fiber protrudes distally from the distalsurface of the treatment guide when the optical fiber is receivedthrough the at least one aperture of the treatment guide, wherein thethickness of the treatment guide and the length of the optical fiber aredimensioned so that the distal end of the optical fiber protrudesdistally by at least 0.25 mm from the distal surface of the treatmentguide when the optical fiber is received thought the aperture of thetreatment guide.
 24. The ophthalmic treatment system of claim 22,wherein the treatment guide comprises a contact ring with a plurality ofapertures extending from the proximal surface to the distal surface, theapertures radially spaced about the contact ring, wherein thereplaceable contact tip cooperates with the apertures of the treatmentguide to deliver therapeutic light toward a target tissue at anincidence angle to an optical axis of the eye.
 25. The ophthalmictreatment system of claim 22, wherein the aperture comprises a track andwherein the replaceable contact tip is configured to slidably engagewith the track such that the replaceable contact tip can translate alongthe track while delivering therapeutic light to the target tissue. 26.The ophthalmic treatment system of claim 19, wherein the treatment guidecomprises a perimeter wall configured to engage with an eyelid of thepatient so as to maintain the eyelid open during application of thetreatment guide against the surface of the eye.
 27. A treatment guidefor use with a glaucoma treatment device for delivering therapeuticlight toward an eye of a patient, the treatment guide comprising: aninner edge configured to be aligned with a limbus of the eye, a distalsurface configured to be placed against a surface of a sclera of an eye,and a proximal surface being configured to interface with a distal endof a glaucoma treatment device contact tip to align the contact tip withone or more treatment locations about a ciliary process around the eyeand to control contact pressure of the contact tip on the eye duringdelivery of therapeutic light toward the eye of the patient.
 28. Thetreatment guide of claim 27, wherein a size of the treatment guide isadjustable.
 29. The treatment guide of claim 27, wherein the treatmentguide comprises at least one aperture extending from the proximalsurface to the distal surface, the at least one aperture configured toreceive a distal end of an optical fiber that protrudes from a contactsurface of the contact tip and to align the optical fiber with a targettissue.
 30. The treatment guide of claim 29, wherein the treatment guidecomprises a contact ring and a plurality of apertures extending from theproximal surface to the distal surface, the apertures radially spacedabout the contact ring, wherein the contact tip cooperates with theapertures of the treatment guide to deliver therapeutic light toward thetarget tissue at an incidence angle to an optical axis of the eye. 31.The treatment guide of claim 29, wherein the aperture comprises a trackand wherein the contact tip is configured to slidably engage with thetrack such that the contact tip can translate along the track whiledelivering therapeutic light to the target tissue, wherein the trackextends at least 30 degrees about the optical axis of the eye.
 32. Thetreatment guide of claim 27, wherein the treatment guide comprises aperimeter wall configured to engage with an eyelid of the patient and tomaintain the eyelid open during application of the treatment guideagainst the surface of the eye.
 33. A method for treating glaucoma in aneye of a patient, the method comprising: engaging a proximal end of areplaceable contact tip with a distal end of a handheld treatment devicehousing to optically couple the replaceable contact tip with atherapeutic light source disposed within the treatment device housing;aligning a distal end of the replaceable contact tip with the ciliaryprocess of the eye; and activating the therapeutic light source togenerate therapeutic light; and delivering the therapeutic light withthe replaceable contact tip toward the ciliary process of the eye. 34.The method of claim 33, further comprising applying a treatment guide tothe eye, and wherein aligning the distal end of the replaceable contacttip with the ciliary process of the eye comprises engaging the distalend of the replaceable contact tip with the treatment guide after thetreatment guide is applied to the eye.
 35. The method of claim 34,wherein the treatment guide comprises a ring and is positioned over thesclera of the eye of the patient, wherein the treatment guide comprisesa plurality of separate apertures configured to receive a distal end ofan optical fiber of the replaceable contact tip therethrough.
 36. Themethod of claim 35, wherein the replaceable contact tip engages with theapertures of the treatment guide to deliver therapeutic light toward theciliary process at an incidence angle to an optical axis of the eye. 37.The method of claim 35, wherein the distal end of the optical fiber ofthe replaceable contact tip protrudes from a contact surface of thetreatment guide and indents the surface of the eye.
 38. The method ofclaim 34, wherein the treatment guide comprises a track and ispositioned over the sclera of the eye of the patient, wherein thereplaceable contact tip slidably engages with the track and wherein thereplaceable contact tip is translated along the track during delivery ofthe therapeutic light to the ciliary process.
 39. The method of claim34, wherein the treatment guide comprises a perimeter wall configured toengage with an eyelid of the patient, and wherein the perimeter wall ofthe treatment guide maintains the eyelid open during application of thetreatment guide to the eye.
 40. The method of claim 33, furthercomprising removing a prior contact tip from the treatment devicehousing prior to engaging the proximal end of the replaceable contacttip with the distal end of the treatment device housing, wherein thereplaceable contact tip comprises a first computer readable code,wherein the treatment device housing includes a scanner for detectingthe first computer readable code, and wherein parameters of thetherapeutic light source are adjusted after detection of the firstcomputer readable code by the scanner.
 41. The method of claim 33,further comprising selecting between a plurality of alternativereplaceable contact tips for engagement with the treatment device,wherein the replaceable contact tips have differing contact surfacegeometries.
 42. The method of claim 33, further comprising selectingbetween a plurality of alternative treatment guides for engagement withthe replaceable contact tip, wherein the treatment guides have differingsizes, apertures, or thicknesses.